ATCP 65.28(7)(f)
(f) The division may authorize an alternative cleaning and sanitizing schedule for continuously-operated equipment, in lieu of the schedule under par.
(b), based on a proposal under par.
(g). The division's authorization of a proposal for cleaning and sanitizing of equipment in contact with grade A dairy products is contingent upon consultation with, and acceptance of the proposal by, the US food and drug administration, and shall be valid for 5 years. The division's authorization may be renewed after a review requested in writing by the dairy plant operator. A dairy plant operator shall adhere to the practices described in an approved proposal. A dairy plant operator may not alter practices described in an approved proposal without division approval. Division approval of a proposed changes for cleaning and sanitizing of equipment in contact with grade A dairy products is contingent upon consultation with, and acceptance of the changes by, the US food and drug administration, and shall be valid for 5 years.
ATCP 65.28(7)(g)
(g) A dairy plant operator's proposal, under par.
(f), shall include all of the following:
ATCP 65.28(7)(g)1.
1. A complete description of the continuously-operated equipment covered by the proposal, including relevant design and sanitation features.
ATCP 65.28(7)(g)2.
2. A complete description of the processing, handling, or storage operations for which the continuously-operated equipment is used. The description shall identify the types of dairy products involved, and the type and duration of continuous operations conducted.
ATCP 65.28(7)(g)3.
3. A complete description of the cleaning and sanitizing procedure proposed by the dairy plant operator. The description shall include cleaning and sanitizing frequency, cleaning and sanitizing methods and materials, and other relevant process parameters such as time, temperature, and concentration. The description shall include relevant process diagrams and specifications.
ATCP 65.28(7)(g)4.
4. A certification, by the dairy plant operator, that the proposed cleaning and sanitizing procedure complies with par.
(a). The certification shall be based on a thorough hazard analysis and safety assessment by qualified personnel.
ATCP 65.28(7)(h)
(h) A dairy plant operator shall keep records to document, on an ongoing basis, the operator's compliance with this subsection.
ATCP 65.28(8)
(8) Storing clean equipment and utensils. Clean equipment and utensils, unless stored in an approved sanitizing solution, shall be stored so that they drain dry. Utensils and equipment components disassembled for cleaning shall be stored above the floor in metal racks or other storage facilities which allow drainage. Clean equipment and utensils shall be protected from contamination prior to use.
ATCP 65.28(9)
(9) Single-service utensils. Single-service utensils shall be stored in the original containers in which they were received, or in other closed containers that will protect them from contamination until they are used. Single-service utensils shall not be reused.
ATCP 65.28(10)
(10) Cleaning compounds, detergents, and sanitizers; storage and labeling. Cleaning compounds, detergents, and sanitizers used in a dairy plant shall be clearly labeled. When they are not being used, they shall be stored in designated areas and in an appropriate manner so that they do not contaminate dairy products, ingredients, equipment, or utensils.
ATCP 65.28 History
History: CR 14-073: cr.
Register August 2016 No. 728, eff. 9-1-16; correction in (7) (b) made under s.
13.92 (4) (b) 7., Stats.,
Register August 2016 No. 728;
correction in (7) (b) made under s. 13.92 (4) (b) 7., Stats., Register January 2020 No. 769. ATCP 65.30(1)(1)
Construction and maintenance; general. C-I-P systems shall be designed, constructed, installed, and maintained in compliance with s.
ATCP 65.28.
ATCP 65.30(2)(a)(a) A dairy plant operator shall clean and sanitize all C-I-P systems in compliance with s.
ATCP 65.28 (7). Surfaces that cannot be cleaned and sanitized by C-I-P procedures shall be cleaned and sanitized manually or by a clean-out-of-place mechanical process.
ATCP 65.30(2)(b)
(b) A dairy plant operator shall keep records on the cleaning and sanitizing of all C-I-P systems. The records shall identify every C-I-P system that has been cleaned and sanitized, the date and time when each C-I-P system was cleaned and sanitized, the temperature of the cleaning and sanitizing solutions, and the length of time for which the C-I-P system was exposed to the cleaning and sanitizing solutions. Records shall be made at the time the cleaning and sanitizing process is completed. Records shall be signed or initialed by a responsible person at the dairy plant. The division shall review the records as part of every routine inspection of the dairy plant.
ATCP 65.30(3)(a)
(a) Before installing a C-I-P system or adding equipment to any existing C-I-P system, the dairy plant operator shall submit to the division a plan for the installation or addition. The plan shall clearly describe each C-I-P circuit at a level of detail sufficient to permit review by the division within the time periods specified under this subsection.
ATCP 65.30(3)(b)
(b) Plans for a C-I-P system, under par.
(a), shall include the manufacturer's specifications for the system, including the manufacturer's specifications for operating, maintaining, cleaning, and sanitizing the system.
ATCP 65.30(3)(c)
(c) Within 20 business days after any person files plans with the division under this subsection, the division shall return its comments or objections, if any, in writing.
ATCP 65.30 History
History: CR 14-073: cr.
Register August 2016 No. 728, eff. 9-1-16.
ATCP 65.32(1)(a)(a) Dairy product packages shall be of sanitary design and construction. Packages shall be designed and constructed to protect packaged dairy products from reasonably foreseeable contaminants.
ATCP 65.32(1)(b)
(b) Product contact surfaces of dairy product packages shall be smooth, nontoxic, noncorrosive, nonabsorbent, and durable under foreseeable use conditions. Product contact surfaces shall not impart any odor, color, taste, or adulterating substance to packaged dairy products.
ATCP 65.32(1)(c)
(c) Dairy product packages shall be clean, sanitary, and free of any extraneous or deleterious substance. Dairy products shall not be sold or distributed in packages with a broken seal or that are damaged to the extent that package contents could become adulterated as a result of the damage.
ATCP 65.32(1)(d)
(d) Single-service packages shall be made of clean and sanitary materials, shall be protected from contamination prior to use, shall be handled in a sanitary manner, and shall be clean and sanitary at the time of use. Single service packages shall not be re-used.
ATCP 65.32(2)(a)
(a) The residual bacteria count on product contact surfaces of grade A dairy product packages shall not exceed one per milliliter of capacity when the rinse test is used, or 50 per 8 square inches (one per square centimeter) when the swab test is used, in 3 out of 4 samples randomly taken and analyzed on a given day. Product contact surfaces shall be free of coliform bacteria as determined using a rinse test or a swab test.
ATCP 65.32(2)(b)
(b) A grade A dairy product package shall be designed so that the product, the package pouring lip if any, and the package opening rim and area are protected from contamination during handling, storage, and initial opening. A grade A dairy product package shall be designed so that it cannot be opened without breaking the cap or closure seal, or leaving other readily apparent evidence that the package has been opened.
ATCP 65.32(2)(c)
(c) Product contact surfaces of multi-use packages used for grade A milk or dairy products shall be constructed of one or more of the following materials unless the division specifically authorizes another material in writing:
ATCP 65.32(2)(c)1.
1. Stainless steel of the Iron and Steel Institute 300 series or an equally corrosion resistant metal.
ATCP 65.32(2)(c)3.
3. Plastic materials that maintain their original properties under repeated use conditions; that are fat resistant and insoluble; and that are resistant to scratching, scoring, decomposition, crazing, chipping, and distortion under normal use conditions.
ATCP 65.32(2)(d)
(d) Product contact surfaces of multi-use packages used to contain grade A milk or dairy products shall have rounded corners, and shall be easily cleanable.
ATCP 65.32(2)(e)
(e) Multi-use packages used to contain grade A milk or dairy products shall be effectively cleaned and sanitized before being reused. Cleaning and sanitizing procedures shall remove all extraneous matter and potential adulterants from each package. Sanitizing procedures shall comply with s.
ATCP 65.34. If returnable glass bottles are sanitized in an automatic bottle washer by soaking those bottles in a caustic solution, the sanitizing procedure shall comply with sub.
(3).
ATCP 65.32(2)(f)
(f) Multi-use packages used to contain grade A milk or dairy products shall be inspected before they are reused. Inspection shall be adequate to detect extraneous materials, adulterants, and damage to product contact surfaces. Inspection shall be performed on surfaces lighted in compliance with s.
ATCP 65.24 (5) (c).
ATCP 65.32(2)(g)
(g) No multi-use plastic package may be reused for grade A milk or dairy products unless that package is tested for the presence of volatile organic compounds using method ASTM D 3530 or an equivalent method approved by the department before the package is filled. An automatic testing device, capable of detecting volatile organic compounds at levels of public health significance, shall be used to test each package. The testing device shall be installed in conjunction with the dairy product packaging apparatus so that no packages can be filled unless the testing device is operating properly, and so that packages containing unsatisfactory levels of volatile organic compounds are automatically made unusable. The dairy plant operator shall test the system daily with a test solution consisting of 0.5 ppm petroleum distillate or another test solution approved in writing by the division.
ATCP 65.32 Note
Note: A copy of ASTM D 3530 may be obtained from ASTM International, P.O. Box C700, West Conshohocken, PA 19428-2959; 1-877-909-2786;
www.astm.org.
ATCP 65.32(2)(h)
(h) No plastic multi-use package may be used to contain grade A milk or dairy products unless all of the following requirements are met:
ATCP 65.32(2)(h)1.
1. The package is identified to show the plant at which the package was manufactured, the date of manufacture, and the type and class of plastic material used. This information may be coded if the code is provided to the division.
ATCP 65.32(2)(h)3.
3. The division has provided a written approval of a prototype of the package.
ATCP 65.32(2)(i)
(i) Single-service packages used to contain grade A milk or dairy products shall be manufactured by a manufacturer listed in the “Certified Manufacturers of Single-Service Containers and Related Products" published online by the Food and Drug Administration, Public Health Service, United States Department of Health and Human Services.
ATCP 65.32 Note
Note: Copies of "Certified Manufacturers of Single-Service Containers and Related Products" are available online at
http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2007965.htm or from the Milk Safety Team, HFS-626, Food and Drug Administration, Public Health Service, United States Department of Health and Human Services, 5100 Paint Branch Parkway, College Park, MD 20740-3835.
ATCP 65.32(2)(j)
(j) Packaged grade A milk and dairy products shall be conspicuously labeled as grade A milk or dairy products.
ATCP 65.32(3)(a)
(a) Returnable glass bottles cleaned in an automatic bottle washer shall be sanitized while in the washer. Bottles cleaned in an automatic bottle washer may be sanitized by being soaked in a caustic solution. The causticity of the sanitizing solution shall be monitored and maintained at an appropriate level in relation to solution temperature and soaking time. Table 1 shows minimum causticity levels required for sanitizing solutions, expressed in terms of percent concentration of sodium hydroxide (NaOH) in the sanitizing solution, based on applicable soaking times and temperatures.
ATCP 65.32(3)(b)
(b) After being soaked in caustic solution under par.
(a), bottles shall be rinsed with water that has been treated with heat or chemicals to destroy viable pathogenic or other harmful microorganisms that may be present in the rinse water.
-
See PDF for table 
ATCP 65.32(4)(a)(a) Grade A dairy products shall be packaged in a sanitary manner at the dairy plant where they are pasteurized.
ATCP 65.32(4)(b)
(b) Grade A dairy products shall be mechanically packaged using mechanical capping, closing, or sealing equipment approved by the division. When mechanical equipment for capping, closing, or sealing containers holding 3 gallons (12.8 liters) or more is not available, manual methods approved by the division may be used. Hand capping is otherwise prohibited.
ATCP 65.32(4)(c)
(c) A drip deflector, designed and adjusted to deflect condensation away from open packages, shall be installed on each filler valve.
ATCP 65.32(4)(d)
(d) Conveyors that feed packages to packaging machines shall have overhead shields to protect open packages from contamination.
ATCP 65.32(4)(e)
(e) If a filled package is imperfectly sealed, the contents of that package shall be emptied into a sanitary container. The contents shall be discarded or shall be examined for physical adulterants, filtered if necessary, and repasteurized before being repackaged.
ATCP 65.32 History
History: CR 14-073: cr.
Register August 2016 No. 728, eff. 9-1-16.
ATCP 65.34
ATCP 65.34
Sanitizers and sanitizing methods. ATCP 65.34(1)(1)
Sanitizing methods. Cleaned product contact surfaces shall be sanitized by using any of the following methods:
ATCP 65.34(1)(a)
(a) Complete and continuous exposure to clean water at a temperature of at least 170
° F. (70
° C.) for at least 5 minutes.
ATCP 65.34(1)(b)
(b) Complete and continuous exposure to steam resulting in a food contact surface temperature of at least 170
° F. (70
° C.) for at least 15 minutes or resulting in a food contact surface temperature of at least 200
° F. (93
° C.) for at least 5 minutes.
ATCP 65.34(1)(c)
(c) Complete and continuous exposure for at least 2 minutes to a sanitizing solution containing at least 50 ppm of free residual chlorine and having a pH not higher than 8.3, at a temperature not less than 75
° F. (24
° C.) or more than 110
° F. (44
° C.)
ATCP 65.34(1)(d)
(d) Complete and continuous exposure for at least one minute to a sanitizing solution containing at least 12.5 ppm of available iodine and having a pH not higher than 5.0, at a temperature of not less than 75
° F. (24
° C.) or more than 110
° F. (44
° C.).
ATCP 65.34(1)(f)
(f) Application
of chemical sanitizers that comply with
21 CFR 178.1010, are registered with the U.S. environmental protection agency and applied according to manufacturer's instructions.
ATCP 65.34(1)(g)
(g) Application of a chemical sanitizer or sanitizing method that has been shown to be as effective as the methods specified under pars.
(a) to
(f), and that the division has approved in writing.
ATCP 65.34(2)
(2) Sanitizers; maximum concentrations. The use of a sanitizer shall leave no toxic residue on a product contact surface. Sanitizing solutions shall not exceed the maximum concentrations specified by the US food and drug administration, under
21 CFR 178.1010. A test kit or other device that measures the concentration of sanitizing solutions in appropriate units of measurement shall be used as necessary to ensure compliance with this subsection at all times.
ATCP 65.34 History
History: CR 14-073: cr.
Register August 2016 No. 728, eff. 9-1-16.
ATCP 65.36
ATCP 65.36
Receiving milk and dairy products. ATCP 65.36(1)(a)
(a) No dairy plant operator may collect or receive milk from a dairy farm located in this state, unless the milk producer holds a current milk producer license for that dairy farm under s.
97.22 (2), Stats., and s.
ATCP 65.02.
ATCP 65.36(1)(b)
(b) No dairy plant operator may collect or receive a milk shipment from a dairy farm in this state unless a person, licensed under s.
97.17 or
98.146, Stats., does all the following before that milk shipment is commingled with milk from any other dairy farm:
ATCP 65.36(1)(b)2.
2. Accurately measures and records the temperature and quantity of milk in the shipment.
ATCP 65.36 Note
Note: A dairy plant operator shall comply with applicable requirements under subch. V, which requires dairy plant operators to sample and test producer milk and report test results. Dairy plant operators must reject milk shipments and take follow-up action in some cases.
ATCP 65.36(2)
(2) Grade A milk from dairy farms. No dairy plant operator may collect or receive as grade A milk any of the following:
ATCP 65.36(2)(b)
(b) Milk from a dairy farm in any other state, unless the milk producer holds a current grade A permit for that dairy farm from the responsible regulatory authority in that state.
ATCP 65.36(3)(a)(a) No dairy plant operator may receive or ship any grade A milk or grade A fluid milk products transported in a bulk milk tanker, unless the bulk milk tanker operator holds a current grade A permit for that bulk milk tanker issued under s.
97.21 (2), Stats., and s.
ATCP 82.02 (7) or issued by another state's regulatory agency.
ATCP 65.36(3)(b)
(b) Before a dairy plant operator unloads milk from a bulk milk tanker or commingles it with milk from another milk producer, the dairy plant operator shall test the bulk shipment for drug residues according to s.
ATCP 65.72 (3).
ATCP 65.36(3)(c)
(c) An on-farm dairy plant may not receive milk from the same dairy farm which is transported by means other than a bulk milk tanker unless each bulk shipment of milk is sampled and the milk is tested for drug residues according to s.
ATCP 65.72 (3). After the sampling, all remaining unpasteurized milk shall be pasteurized and all equipment that contacted the unpasteurized milk shall be cleaned and sanitized before the next receipt of unpasteurized milk by the dairy plant. The sample of milk shall be obtained from one of the following locations:
ATCP 65.36(3)(c)2.
2. An unpasteurized milk tank, silo, other unpasteurized milk storage container, or vat pasteurizer raw milk receptacle in the dairy plant.
ATCP 65.36(4)
(4) Grade A dairy plant may not receive grade B milk. A grade A dairy plant operator may not process grade B milk at a grade A dairy plant unless the division authorizes that processing in writing. A grade A dairy plant operator may not receive, transfer, or process grade A milk or dairy products through the same equipment used to receive, transfer, or process grade B milk or dairy products unless the dairy plant operator first rinses the equipment.
ATCP 65.36(5)
(5) Manufactured dairy ingredients; approved sources. Manufactured dairy ingredients used in the manufacture or processing of dairy products shall originate from dairy plants licensed under s.
97.20, Stats., and this chapter, or licensed or inspected under laws of other states or nations deemed acceptable by the FDA.
ATCP 65.36(6)(a)
(a) A dairy plant's facilities for receiving milk shipments shall be constructed and maintained in compliance with s.
ATCP 65.24 and shall be separated from other areas of the dairy plant as required by s.
ATCP 65.24 (7).
ATCP 65.36(6)(b)
(b) An on-farm dairy plant may not receive milk from the same dairy farm unless the milk is transported in a bulk milk tanker and received in a facility complying with s.
ATCP 65.24 or stored on the dairy farm in a bulk milk tank or silo that is directly connected to an raw milk tank, silo, other raw milk storage container, or vat pasteurizer raw milk receptacle in the dairy plant.
ATCP 65.36(7)
(7) Cleaning and sanitizing bulk milk tankers. A dairy plant operator shall ensure that bulk milk tankers transporting milk or dairy products to or from a dairy plant are cleaned and sanitized after each day's use as required by s.
ATCP 82.08.
